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NCT Number: NCT05799521

A Nasal Treatment for COVID-19

The goal of this study is to test an investigational new inhaled medication called Optate.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Healthy Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

About this study

The goal of this study is to test an investigational new inhaled medication called Optate. Investigational means it has not been approved by the Food and Drug Administration (FDA) for this use. The investigators hypothesize that Optate will reduce the length of symptoms and disease severity in patients with COVID-19 (Coronavirus disease of 2019) through inhibition of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) viral replication within the upper and lower airways. Testing this hypothesis is important because treatments for COVID-19 are needed alongside vaccines. COVID-19 begins in the nasal passages, so targeted therapies to the nasal passages at early stages of the disease may prevent severe disease from occurring.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

COVID-19 PARTICIPANTS Inclusion Criteria: Subjects, 18 and above, with mild COVID-19 upper respiratory tract infection symptoms

  • positive rapid COVID-19 test
  • Ordinal Scale for Clinical Improvement < 3 (OSCI, Appendix 2) and/or
  • Fever > 100 degree F and/or
  • Nasal congestion

Exclusion criteria

  • FEV1 (Forced Exhaled Volume) < 55% predicted on the day of study procedures
  • OSCI ≥ 3 (Objective Structured Clinical Exam)
  • Pregnancy
  • Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

HEALTHY CONTROLS Inclusion Criteria: Subjects, 18 and above, without mild COVID-19 upper respiratory tract infection symptoms

  • negative rapid COVID-19 test
  • No known medical problems or taking any medication that, in the investigator's opinion, would make them unsuitable for participation.

Exclusion criteria

  • Pregnancy
  • Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

Treatment and study plan

Optate

Drug

Alkaline Buffer

Other names: Glycine

Placebo

Drug

Normal Saline

Other names: Normal Saline

Primary outcomes

  1. Change in SARS-CoV-2 Levels

    Time frame: Immediately before and one-hour after treatment

    SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration

  2. Change in SNOT-22 score

    Time frame: Immediately before and one-hour after treatment

    SNOT-22 scores (a validated, 22-item quality of life instrument survey) will be assessed immediately prior to Optate or placebo administration. The SNOT-22 assesses five domains (nasal, ear/facial, sleep, function and emotion) on a Likert scale from 0-5, where 0 means no problems and 5 means the worst possible problems. The total score ranges from 0-110, with higher scores indicating more severe symptoms. Scores will be reassessed one hour after administration.

  3. Change in SNOT-22 score

    Time frame: Immediately before and 24-hours after treatment

    SNOT-22 scores (a validated, 22-item quality of life instrument survey) will be assessed immediately prior to Optate or placebo administration. The SNOT-22 assesses five domains (nasal, ear/facial, sleep, function and emotion) on a Likert scale from 0-5, where 0 means no problems and 5 means the worst possible problems. The total score ranges from 0-110, with higher scores indicating more severe symptoms. Scores will be reassessed 24 hours after administration.

Secondary outcomes

  1. Change in SARS-CoV-2 Levels

    Time frame: Immediately before and one-hour after treatment

    SARS-CoV-2 levels will be measured in exhaled breath condensate before and one hour after Optate or placebo administration

  2. Change in nasal pH

    Time frame: Immediately before, immediately after and one-hour after treatment

    Nasal pH will be measured by a nasal pH meter before, immediately after and one hour after Optate or placebo administration

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

A Novel Nasal Treatment for COVID-19

Acronym: COVD-TX

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 5, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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